Leica Biosystems Richmond Inc. recalls Cell Marque, Microphthalmia Transcription Factor (MiTF) (C5/D5 Mab.), 7 mL, REF PA0803, IVD, The antibody is intended f…

Recall date

July 14, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-3122-2017

FDA classification

Class II

Brand / firm

Leica Biosystems Richmond Inc.

Sold / distributed

Nationwide Distribution to AR, AZ, CA, CT, FL, GA, IL, IN, KY, LA, MI, MN, NC, NH, NV, NY, OR, PA, SC, TN, TX, VA, and WI.

Why it was recalled

A delay in transit may have contributed to nonconformity as the product was stored outside of defined shipping and handling temperature requirements.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Cell Marque, Microphthalmia Transcription Factor (MiTF) (C5/D5 Mab.), 7 mL, REF PA0803, IVD, The antibody is intended for in vitro diagnostic (IVD) use. The Microphthalmia Transcription Factor (MiTF) (C5/D5) antibody is intended for qualified laboratories to qualitatively identify by light microscopy the presence of associated antigens in sections of formalin-fixed, paraffin-embedded tissue sections using IHC test methods.